FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
- For external use only.
- Use only as directed.
- Avoid contact with eyes and mucous membranes.
- Do not cover with bandage.
- Do not use on wounds or damaged skin.
- Consult physician for children under 12.
- Do not use if you are allergic to Menthol.
- Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
- KEEP OUT OF REACH OF CHILDREN.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Releevia MC Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Releevia MC Patch is an external analgesic/counterirritant.
History
There is currently no drug history available for this drug.
Other Information
Releevia MC Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Releevia MC is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.
Releevia MC is a single-use patch stored in a foil pouch. Each Releevia MC patch is 8.3 cm x 12.5 cm (104 cm 2) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.
The empirical formula for capsaicin is C 18H 27NO 3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:
The empirical formula for menthol is C 10H 20O, with a molecular weight of 156.27. The chemical compound menthol [(1 R,2 S,5 R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:
Each Releevia MC Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Releevia MC patch contains the following inactive ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodiumm Salt, Glycerin, Iodoproynyl Butylcabamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.
Sources
Stoul 40 Manufacturers
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Paramesh Banerji Life Sciences Llc
Stoul 40 | Patchwerx Labs, Inc
Releevia MC patch contains 0.0375% capsaicin and 5.00% menthol.
Instructions for Use
Clean and dry affected area Cut open pouch and remove patch Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patchesDirections
Adults and children 12 years and over apply to affected area change patch 1 to 2 times daily Children under 12 years consult physician before use
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